Automated oxygen control in preterm babies on respiratory support: protocol for a randomised crossover trial.

IF 2 4区 医学 Q2 PEDIATRICS
Hafiz Muhammad Aamir Yousuf, Ali Shabbir Hussain, Georg M Schmolzer, Zahra Hoodbhoy, Rabia Munir, Arjumand Rizvi, Uzma Khan
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引用次数: 0

Abstract

Introduction: Respiratory support is frequently needed for babies admitted to the neonatal intensive care unit. Among them, preterm babies are most likely to have issues of respiratory distress, and they may need invasive or non-invasive breathing support. Providing respiratory support, keeping the oxygen saturation (SpO2) in the target range (TR) and preventing abnormal high and low oxygen levels should be the aim of providing respiratory therapy. Usually, this control is achieved by manual adjustment of FiO2 (fraction of inspired oxygen) by bedside staff nurses to keep SpO2 in TR. However, the latest ventilators have automated oxygen control devices that adjust the FiO2 to keep SpO2 in TR. This study protocol is prepared to assess the effectiveness of automated versus manual oxygen control in keeping SpO2 in TR.

Methods and analysis: This is a single-centre, non-blinded, randomised crossover trial that aims to recruit 26 preterm babies who may need invasive or non-invasive respiratory support. The 12-hour periods of automated oxygen control by ventilator will be compared with 12 hours of manual oxygen control by bedside staff nurse. The primary outcome will compare both interventions and will assess their efficacy to keep SpO2 in TR. Secondary outcomes will compare abnormal high and low SpO2 levels, and number and duration of fluctuations in both interventions. Median FiO2 values and median number of manual adjustments of FiO2 will also be compared. Secondary outcomes will also look for the impact of sedative and respiratory stimulant medications on target oxygen saturation.

Ethics and dissemination: The ethics review committee at Aga Khan University Hospital Karachi has given ethical approval for this trial (approval number: 2024-10189-30775). Results from this trial will be published in journals.

Trial registration number: NCT06622161.

呼吸支持下早产儿自动氧气控制:随机交叉试验方案。
简介:呼吸支持是经常需要的婴儿入院新生儿重症监护病房。其中,早产儿最有可能出现呼吸窘迫的问题,他们可能需要有创或无创呼吸支持。提供呼吸支持,保持氧饱和度(SpO2)在目标范围(TR),防止异常的高氧和低氧水平是提供呼吸治疗的目标。通常,这种控制是通过床边工作人员护士手动调节FiO2(吸入氧的分数)来实现的,以保持SpO2在TR中。然而,最新的呼吸机具有自动氧气控制装置,可调节FiO2以保持SpO2在TR中。本研究方案旨在评估自动与手动氧气控制在保持SpO2在TR中的有效性。这是一项单中心、非盲、随机交叉试验,旨在招募26名可能需要侵入性或非侵入性呼吸支持的早产儿。将呼吸机自动控氧12小时与床边护理人员手动控氧12小时进行比较。主要结局将比较两种干预措施,并评估其在TR中保持SpO2的功效。次要结局将比较两种干预措施的异常高、低SpO2水平,以及波动的次数和持续时间。还将比较FiO2的中位数值和手动调整FiO2的中位数数。次要结果也将寻找镇静和呼吸兴奋剂药物对目标氧饱和度的影响。伦理和传播:卡拉奇阿迦汗大学医院伦理审查委员会已对该试验给予伦理批准(批准号:2024-10189-30775)。这项试验的结果将发表在期刊上。试验注册号:NCT06622161。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
BMJ Paediatrics Open
BMJ Paediatrics Open Medicine-Pediatrics, Perinatology and Child Health
CiteScore
4.10
自引率
3.80%
发文量
124
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